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Clinical Trial Summary

Over 1.37 million Caesarian sections (C-sections) are performed annually in the US . It is estimated that 12-20 % of those will result in chronic scar pain. This pain can lead to functional difficulties performing activities of daily living, pain with bowel movements, and pain with sexual activity . There is anecdotal evidence supporting the use of deep fascial scar mobilization techniques in reducing abdominal surgical scar pain, and yet almost no research has been published. The aims of this randomized clinical trial will be to determine if deep fascial scar mobilization techniques or superficial scar mobilization techniques will improve chronic pain and its resulting functional deficits, threshold pressure discomfort, pressure tolerance and mobility restrictions resulting from C-section surgery and to see if these interventions are more effective than no intervention. A positive result may result in an increase in the use of this intervention and thus the reduction of chronic scar pain for many women; it may provide justification for insurance reimbursement for this approach and it will also pave the way for further investigation into the use of these techniques with other types of painful scars including hysterectomy.


Clinical Trial Description

Methods: Thirty six subjects will be recruited who have a history of C-section surgery more than three months before entering the study and who report chronic pain in or around the scar stemming from the surgery. Subjects will initially be tested twice four weeks apart, before beginning intervention. This will allow the establishment of a baseline and the subjects will all be part of a baseline control group. They will then be randomly assigned to one of two treatment groups. Group 1 will undergo four, 25 minute sessions of light massage to the trunk followed by superficial skin rolling of the C-section scar. Group 2 will undergo four, 25-minute treatment sessions consisting of multi-planar pelvic and abdominal myofascial mobilization techniques and direct scar mobilization techniques..

Outcomes: Outcome measures will include threshold pressure discomfort and pressure tolerance using a Pressure Algometer, Adheremeter measurements of scar mobility, the numeric pain rating scale (NPRS), the Oswestry Disability Index (ODI), Hip extension and shoulder flexion measured via goniometery, and the Global rating of Change scale. Follow up measures will be collected four weeks following the start of interventions and again at 12 weeks. In addition qualitative data will be collected from the subjects. The treating therapist will be blinded to the results of the outcome measures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02836626
Study type Interventional
Source Rocky Mountain University of Health Professions
Contact
Status Active, not recruiting
Phase N/A
Start date June 2016
Completion date August 2017

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